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NCT02029820 Clinical Trial

RenalGuard System for Prevention of Contrast Induced Nephropathy

Radiographic Contrast Agent Nephropathy Clinical Trial

— REPRECIN  

Official title:
RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02029820
Other study ID # 11/05339
Secondary ID
Status Recruiting
Phase Phase 3
First received January 6, 2014
Last updated January 6, 2014
Start date August 2012
Est. completion date December 2015

Study information
Verified date January 2014
Source Hospital Sao Lucas da PUCRS
Contact Aryadina Piva, RN
Phone 55 51 33203494
Email pesquisa@cardiarte.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- serum creatinine >1.2mg/dl

- glomerular filtration rate (GFR) < 60ml/min

Exclusion Criteria:

- acute renal failure

- use of radiological contrast in the latest 7 days

- Current use of N-acetylcysteine or hydration of sodium bicarbonate

- Patients in dialysis

- Emergency procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• RenalGuard
Intravenous saline hydration matched with urine output, using the device Renalguard

Locations
Country Name City State
Brazil Hospital São Lucas -PUCRS, Serviço de Hemodinâmica Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Lucas da PUCRS

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of contrast-induced nephropathy Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure 72 hours No
See also
  Status Clinical Trial Phase
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Recruiting NCT00584350 - Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP Phase 4
Recruiting NCT01820195 - N-Acetyl Cystein and Contrast Nephropathy Phase 3
Completed NCT02137863 - Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy Phase 4
Completed NCT01866800 - The Effect of the Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During TAVI Phase 4
Active, not recruiting NCT01778140 - Comparing Effects of Patient-specific Versus Non-patient-specific Computerized Reminder System N/A
Completed NCT02483143 - NAC, NaHCO3 and NS Prophylaxis for CTPA in the ED on Suspicion of PE: A Randomized Controlled Trial Phase 4
Completed NCT01525888 - Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy N/A
Recruiting NCT02643706 - Relationship Between ALDH2 and CIN N/A
Terminated NCT01168024 - Contrast Media Reduction and Removal in Patients With CKD (PRESERV) Phase 3
Completed NCT02643602 - Does Bicarbonate in Addition to Theophylline Reduce CIN? N/A
Terminated NCT01654328 - Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy N/A